Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

Phase 1

• Conditions: Adolescent Depression

• Registration Number: NCT01170520
• Lead Sponsor: Shalvata Mental Health Center

Brief Summary

The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients.

A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Study Start: 2010-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-05
• Primary Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age 15-18 years old
• Right hand dominant
• Suffering from major depression
• CDRS > 60
• At least 3 months of current depressive episode
• Failed 2 drug trials (or 3 drug trials if trial terminated prematurely due to side effects) and at least 1 course of psychotherapy
• No contraindication for rtms (safety questionnaire)
• No change in pharmacotherapy in the last month

Exclusion Criteria

• Schizophrenia or psychotic symptoms
• Hypertension
• Epilepsy
• History of major head trauma
• Metal implements in the head
• History of neurosurgery
• History of severe head migraine
• History of hearing loss or sp cochlear transplantation
• Pregnancy
• Current drug abuse
• Unstable medical condition
• History of manic episode
• Current treatment with lithium or tricyclic or tetracyclic antidepressants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Child Depression Rating Scale (CDRS) comparison before after therapy	4 weeks

Trial Locations

Locations (2)

Shalvata Mental health Center; 🇮🇱 Hod Hasharon, Israel

Shalvata Mental Health Center; 🇮🇱 Hod Hasharon, Israel